FDA 510(k) Application Details - K243344

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K243344
Device Name	Cerclage, Fixation
Applicant	Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 US Other 510(k) Applications for this Company
Contact	Emmarie Halteman Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2024
Decision Date	02/20/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review